RecruitingPhase 1NCT06543667

Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye

A Clinical Study for Safety and Efficacy Evaluation of Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye Syndrome


Sponsor

Iran University of Medical Sciences

Enrollment

30 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes (LSC-Exo) in alleviation of dry eye symptoms


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • Patients with complaints of burning or itching or feeling of a foreign body in the eye
  • Moderate and severe dry eye severity
  • Age between 18-70 years

Exclusion Criteria7

  • Previous history of eye surgery
  • Any disease that suppresses the immune system
  • Pregnancy and breastfeeding
  • Eyelid abnormalities
  • Use of eye drops in the past year except artificial tears and lubricating ointments
  • Use of systemic drugs that affect the tear film in last three months
  • Use of contact lenses in the last three months

Interventions

BIOLOGICALLimbal Stem Cell Derived Exosomes Eye Drop

Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drops 0.15 ml/single eye/one time, four times a day for 3 months. The follow-up visit will be 12 weeks since the administration of LSC-Exo eye drops.


Locations(1)

Moheb Kowsar Hospital

Tehran, Iran

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NCT06543667


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